MigrainePhase 3NCT00812006

A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis

A Phase 3 study testing rizatriptan benzoate in people with Migraine, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Migraine
What is being tested?: rizatriptan benzoate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 108 participants
Where: No sites listed yet
Study dates: 24 Mar 2009to 22 Oct 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has a history of migraine with or without aura for more than one year, with between 2 and 8 moderate to severe attacks per month
Patient is currently taking at least 50 mg topiramate daily for migraine prophylaxis
Patient can distinguish between migraine and other types of headache
Patient agrees to remain abstinent or use effective birth control during the study

Who cannot join

Patient is pregnant or breast-feeding
Patient has a history of mostly mild migraines or migraines that resolve within 2 hours
Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in the 3 months prior to screening.
Patient was > 50 years old at age of migraine onset
Patient has history of heart disease
Patient has uncontrolled hypertension

Show all 10Show fewer

Patient has had cancer within 5 years of screening (excepting certain skin and cervical cancers)
Patient has started taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) or has changed doses within 3 months of screening
Patient is taking more than one other migraine prophylactic medication
Patient has repeatedly failed to respond to or tolerate rizatriptan

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg ODT for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis

This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis.

Conditions: Migraine
Being tested: rizatriptan benzoate, Comparator: placebo
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rizatriptan benzoateDrug
Also called Maxalt
rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack
Comparator: placeboDrug
Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack

Study groups in NCT00812006
Study group	Role	What they receive
A	Experimental	Treatment Sequence A: rizatriptan, rizatriptan, placebo Receives: Drug: rizatriptan benzoate; Drug: Comparator: placebo
B	Experimental	Sequence B: rizatriptan, placebo, rizatriptan Receives: Drug: rizatriptan benzoate; Drug: Comparator: placebo
C	Experimental	Sequence C: placebo, rizatriptan, rizatriptan Receives: Drug: rizatriptan benzoate; Drug: Comparator: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Relief (PR)
Pain severity was rated by the participants in a paper diary. Pain severity rating scale : 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.
Measured: 2 hours post dose

Secondary outcomes (4)

Sustained Pain Relief (SPR)
24-hour sustained pain relief (defined as pain relief at 2 hours post dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the respective period after dosing with the blinded study medication.
Measured: 2 - 24 hours post dose
Pain Freedom (PF)
Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.
Measured: 2 hours post dose
Normal Rating of Functional Disability (NRFD)
Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired, or unable to do activities, requires bedrest. Functional disability ratings was dichotomized to Normal and Not Normal (mildly impaired, severely impaired, or unable to do activities, requires bedrest) for analysis.
Measured: 2 hours post dose
Treatment Satisfaction (TS)
Patient satisfaction was assessed on a paper diary by the participants. Level of satisfaction was rated as: completely satisfied, very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied. The overall 24-hour assessment of study medication was dichotomized to Satisfaction (completely satisfied, very satisfied, somewhat satisfied) and Non-satisfaction (neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied) for analysis.
Measured: 24 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Mar 200922 Oct 2009

First posted19 Dec 2008 (estimated)
Study start24 Mar 2009
Primary completion22 Oct 2009
Study completion22 Oct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MigraineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00812006
Sponsor's protocol ID: 0462-085
Other IDs: 2008_597
Status last verified: Feb 2022
First submitted: 17 Dec 2008
Last updated: 23 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Seeburger JL, Cady RK, Winner P, MacGregor A, Valade D, Ge Y, Zhang Y, Hustad CM, Strickler N, Schaefer E, Connor KM, Ho TW. Rizatriptan for treatment of acute migraine in patients taking topiramate for migraine prophylaxis. Headache. 2012 Jan;52(1):57-67. doi: 10.1111/j.1526-4610.2011.02027.x. Epub 2011 Nov 11.
PubMed 22078129

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg ODT for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis
ClinicalTrials.gov ID: NCT00812006
Acronym / sponsor ID: 0462-085
Conditions: Migraine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 24 Mar 2009 (actual)
Primary completion: 22 Oct 2009 (actual)
Study completion: 22 Oct 2009 (actual)
First posted: 19 Dec 2008 (estimated)
Results: Posted 27 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
A	Experimental	Drug: rizatriptan benzoate, Drug: Comparator: placeboTreatment Sequence A: rizatriptan, rizatriptan, placebo
B	Experimental	Drug: rizatriptan benzoate, Drug: Comparator: placeboSequence B: rizatriptan, placebo, rizatriptan
C	Experimental	Drug: rizatriptan benzoate, Drug: Comparator: placeboSequence C: placebo, rizatriptan, rizatriptan

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patient has a history of migraine with or without aura for more than one year, with between 2 and 8 moderate to severe attacks per month
Patient is currently taking at least 50 mg topiramate daily for migraine prophylaxis
Patient can distinguish between migraine and other types of headache
Patient agrees to remain abstinent or use effective birth control during the study

Key exclusion criteria (10 listed)

Patient is pregnant or breast-feeding
Patient has a history of mostly mild migraines or migraines that resolve within 2 hours
Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in the 3 months prior to screening.
Patient was > 50 years old at age of migraine onset
Patient has history of heart disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rizatriptan benzoateAlso: Maxaltrizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack	Drug	A, B, C
Comparator: placeboPlacebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack	Drug	A, B, C

Primary outcome

Pain Relief (PR)
Time frame: 2 hours post dose
Pain severity was rated by the participants in a paper diary. Pain severity rating scale : 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.

4 secondary outcomes

Sustained Pain Relief (SPR)
Time frame: 2 - 24 hours post dose
Pain Freedom (PF)
Time frame: 2 hours post dose
Normal Rating of Functional Disability (NRFD)
Time frame: 2 hours post dose
Treatment Satisfaction (TS)
Time frame: 24 hours post dose

Results and safety

Results posted to the registry on 27 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rizatriptan / Rizatriptan / Placebo	36	30
Rizatriptan / Placebo / Rizatriptan	36	33
Placebo / Rizatriptan / Rizatriptan	36	30

Primary outcome: Pain Relief (PR)

Time frame: 2 hours post dose. Number. Unit: Attacks

Measure	Rizatriptan n = 99	Placebo n = 93
Resulting in PR at 2 hours post dose	105	21
Not resulting in PR at 2 hours post dose	88	72

Rizatriptan vs Placebo: p <0.001, Generalized Linear Mixed Model

Population analysed: Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and at least one post-dose efficacy measurement at or prior to the 2-hour time point.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse experiences were collected up to 14 days after each qualified migraine headache attack that was treated with study medication.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rizatriptan	0 of 101 (0%)	16 of 101 (15.8%)	Not reported
Placebo	0 of 94 (0%)	3 of 94 (3.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22078129Seeburger JL, Cady RK, Winner P, MacGregor A, Valade D, Ge Y, Zhang Y, Hustad CM, Strickler N, Schaefer E, Connor KM, Ho TW. Rizatriptan for treatment of acute migraine in patients taking topiramate for migraine prophylaxis. Headache. 2012 Jan;52(1):57-67. doi: 10.1111/j.1526-4610.2011.02027.x. Epub 2011 Nov 11.
Individual participant dataSharing planned: No

Related trials for Migraine

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rizatriptan benzoate in people with Migraine, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Relief (PR) (time frame: 2 hours post dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00812006, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.